eCOA - Clinical Study Build Programmer

Eli Lilly; Indianapolis (IN); On-site; USD 80,000 - 117,000; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Vacation benefits

Medical, dental, vision coverage

Job summary

Lilly in Indianapolis is seeking a Clinical Study Build Programmer - eCOA to design, program, and test clinical data collection systems for global trials, including mappings, validations and data warehouse integrations.

You will collaborate with Clinical Data Managers, Data Analytics teams and other partners to deliver standardized data collection methods, ensure study objectives are met, and support regulatory submissions.

Qualifications

• Master’s degree in informatics, life sciences, statistics, IT, epidemiology or computer sciences.
• 3+ years of clinical data management or related experience.
• Authorized to work in the United States; no sponsorship expected.

Responsibilities

• Program and test data collection systems and mappings for clinical trials.
• Gather and influence eCOA design specifications and enable localization.
• Develop and test new data delivery ideas and validate data warehouse mappings.
• Support regulatory submission activities and cross-BU projects.
• Collaborate with Clinical Data Managers and analytics partners to ensure study objectives.

Skills

eCOA programming

Clinical data management

Data analysis

Regulatory knowledge

Cross-functional collaboration

Education

Master’s degree in a scientific field

Tools

EDC platforms

Data standards library

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Clinical Study Build Programmer - eCOA is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization and testing. The Clinical Study Build Programmer will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key business partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

Portfolio Delivery

• Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/EDC platforms)
• Study build programming expertise (e.g., form logic, edit checks, workflows, integrations)
• Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
• Gather and influence eCOA design specifications and enable successful implementation
• Understand study translation needs and enable localization
• Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
• Provide insights into the study design and data delivery (i.e. Data Management Plan, Project Plan, database, and observed datasets)
• Support submission, inspection and regulatory response activities
• Lead cross Business Unit/Therapeutic Area projects or programs with high complexity
• Possess a deep understanding of the technology used to collect clinical trial data
• Develops and tests new ideas and/or applies innovative solutions

Project Management

• Increase speed, accuracy, and consistency in the development of systems solutions
• Enable metrics reporting of study development timelines and pre and post production changes to database
• Partner with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visit
• Influence data standard decisions and strategies for a study and/or program
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study database building
• Integrates multi-functional, external information and technical knowledge to support data-driven decision making

Enterprise Leadership

• Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis
• Work to reduce postproduction changes change control process
• Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
• Thinks with end to end in mind consistently managing risk to minimize impact on delivery
• Strong awareness with external developments, timelines
• Focuses on defining database solutions and timelines in support of advancing the portfolio

Minimum Qualification Requirements:

• Master’s degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences
• + 3 years of related experience (or bachelor’s degree plus 5 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...)
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Preferences:

• Experience with designing and handling eCOA data Articulating the flow of data (structure and format) from patient to analysis, applying this knowledge to data solutions
• Deciding the technology platform (system/database) for data acquisition and aggregation Utilization of clinical/drug development knowledge and an ability to liaise with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical, etc.)
• Strong therapeutic/scientific knowledge in the field of research Familiarity with clinical data tools and technologies
• Understanding and experience in using data standards Ability to balance multiple activities, prioritize and manage ambiguity Domestic and International travel may be required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$79,500 - $116,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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